1Contamination control
You produced hazardous drugs without providing adequate containment, cleaning of work surfaces and cleaning of utensils to prevent cross-contamination.
Inspection Record
Lynn Oaks Compounding Pharmacy — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Laboratory and QC controls
Each batch of drug product required to be free of objectionable microorganisms is not tested through appropriate laboratory testing.
3Laboratory and QC controls
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the final specifications and identity and strength of each active ingredient prior to release.
4Equipment and facility
The calibration of instruments is not done at suitable intervals with provisions for remedial action in the event accuracy and/or precision limit:s are not met.
5Stability and storage
There is no written testing program designed to assess the stability characteristics of drug products.
6Material and supplier control
You used a non-pharmaceutical grade component in the formulation of a drug product.
7Equipment and facility
Vermin was observed in your production area.
About this record
Extracted automatically from the document US FDA published on 2022-11-28. The source is available at the link above.
This is a record of that moment. Inspection findings are usually followed by the company's response and corrective action, but this page does not know how that turned out. Do not read it as the current state; check the regulator's official announcements for the latest status.
Translation and classification are automated and may differ in nuance from the source.
